A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 111
- 试验地点
- 18
- 主要终点
- Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
研究概览
简要总结
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
详细描述
The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with pancreatic, duodenal, or small intestine fistula
- •Patient with simple, externalised fistula
- •Patient with fistula for which a medical conservative treatment is considered
- •Patient with:
- •for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
- •for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days
排除标准
- •Patient expected to require a surgical treatment of the fistula during the study
- •Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
- •Patient receiving long-term corticotherapy
- •Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
- •Patient having previously undergone a transplant
研究组 & 干预措施
1
Drug: Lanreotide 30 mg microparticle formulation
One intra-muscular injection.
A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h
For non-responders patients lanreotide will be stopped.
干预措施: Lanreotide microparticles (Drug)
2
One intra-muscular injection.
A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h.
Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
时间窗: Fistula drainage volume on 3rd day.
次要结局
- Pancreatic or duodenal and small intestine fistula closing rate within D60(Day 60)
- Number of injections received by each patient(End of study)
- Percentage of fistula recurrence during the follow-up period(Duration of follow-up period for each patient is of 1 month)
- Percentage of mortality in each group(End of study)
- Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula.(Day 60)